NA 02.211.412Recalls & reported problems
Synthes GmbH · 2.7MM VA-LCKING ANTEROLATERAL CALCANEAL PL LONG 56MM RIGHT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982055026), received between Aug 4, 2023 and Aug 7, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Migration4
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE, DUE TO PLATE PROMINENCE. PATIENT WAS TREATED ON AN UNKNOWN DATE FOR A SEVERELY COMMINUTED RIGHT-SIDE FRACTURE WITH A VARIABLE ANGLE (VA) LOCKING CALCANEAL PLATE AND EIGHT SCREWS. THIS REPORT IS FOR A 2.7MM VA-LCKING ANTEROLATERAL CALCANEAL PL LONG 56MM RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17470490 ↗InjuryAug 4, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A VA LOCKING CALCANEAL PLATE ON AN UNKNOWN DATE FOR A RIGHT COMMINUTED FRACTURE. NINE SCREWS WERE USED FOR FIXATION. HARDWARE REMOVAL WAS PERFORMED AT 24 WEEKS DUE TO PLATE PROMINENCE.
Patient problems: Insufficient Information
MAUDE report 17461791 ↗InjuryAug 4, 2023Migration; Migration
PATIENT# 75. DIABETES MELLITUS: NO. IF INDICATION OF FRACTURE: INTRA-ARTICULAR. POST-OPERATIVE COMPLICATION OCCURRED BECAUSE THERE WAS PROMINENT HARDWARE. THE IMPLANT HAS BEEN IN THE PATIENT FOR 48 WEEKS POST-SURGERY. UNION HAS BEEN ACHIEVED 16 WEEKS POST-SURGERY. IMPLANT DATE : DATES ARE NOT COLLECTED DUE TO DATA PRIVACY REASONS; THE DATA IS ENCODED. THERE WAS AN EXPLANT 48 WEEKS POST-SURGERY. DATES ARE NOT COLLECTED DUE TO DATA PRIVACY REASONS; THE DATA IS ENCODED. THIS REPORT IS FOR ONE (1) 2.7 VA-LCKING ANTEROLAT CALC PL LG 56 RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17461577 ↗InjuryAug 4, 2023Migration; Migration
PATIENT# 45. DIABETES MELLITUS: NO. IF INDICATION OF FRACTURE: INTRA-ARTICULAR POST-OPERATIVE COMPLICATION OCCURRED BECAUSE THERE WAS IMPLANT PROMINENCE. THERE HAS BEEN A REMOVAL/ REVISION SURGERY DUE TO PLATE PROMINENCE. IMPLANT DATE NOT AVAILABLE: THE DATES ARE NOT ALLOWED PER DATA PRIVACY RESTRICTIONS; THE DATA IS ENCODED. EXPLANT DATE NOT AVAILABLE: BUT IT WAS 32 WEEKS POST-SURGERY. THIS REPORT IS FOR ONE (1) 2.7 VA-LCKING ANTEROLAT CALC PL LG 56 RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17461561 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page